# Ciba Corning Diagnostics Corp.

- Location (FDA's records): East Walpole, MA
- FDA decisions: 125 (1986–1996): 125 510(k) clearances
- Product codes: JJY (13), JJE (7), DHB (7), CHL (7), JLW (4), JGS (4), CDD (4), CEP (3), KHQ (3), CDX (3), JHI (3), LJC (3)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 45 (3 its own)
- Recalls linked to its devices: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 11 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Avl Scientific Corp.: 4 (https://510kreport.com/company/avl-scientific)
- Bio-Rad: 3 (https://510kreport.com/company/bio-rad)
- Bayer Healthcare, LLC: 3 (https://510kreport.com/company/bayer-healthcare)
- Diamond Diagnostics, Inc.: 3 (https://510kreport.com/company/diamond-diagnostics)
- Hemodiagnostica, LLC: 2 (https://510kreport.com/company/hemodiagnostica)
- Bayer Diagnostics Corp.: 2 (https://510kreport.com/company/bayer-diagnostics)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K946206: Ciba Corning 8-- Series CO-Oximeter (1995), cited by 6
- K934907: 860 Measurment System (1994), cited by 4
- K962559: Acs Cortisol Immunoassay (1996), cited by 2
- K925277: Ciba Corning Acs HCG Immunoassay (1993), cited by 2
- K934562: Ciba Corning Acs Testosterone Immunoassay (1993), cited by 2
- K902336: Ciba Corning Acs:180 Automated Chemiluminescence (1990), cited by 2

## Recent decisions
- K962559: Acs Cortisol Immunoassay (Nov 5, 1996)
- K963251: Ciba Corning Acs;180 DPD Assay (Oct 15, 1996)
- K961807: Certain HCT Level a & Level B/CVM HCT Levels 1,2,3, & 4 (Jul 26, 1996)
- K961657: Ciba Corning 400 System (Jun 25, 1996)
- K962021: Ciba Corning 348 System (Jun 24, 1996)
- K962126: Acs CKMB II Immunoassay (Jun 21, 1996)
- K962041: Acs LH2 Immunoassay (Jun 21, 1996)
- K961510: Acs FRT4 Immunoassay (Jun 17, 1996)

Source page: https://510kreport.com/company/ciba-corning-diagnostics